BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    ALEUTIAN SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOSITE HAND-CARRIED ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODEL MES-9000/EMG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013

    HOT BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code KGE·April 19, 2011

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 19, 2008

    ALINITY I HAVAB IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·March 26, 2026

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015